FDA Medwatch: RECALL

Press Release: Recall of medications, including Morphine Sulfate Extended Release Tablets, Morphine Sulfate Immediate Release Tablets for pain relief.

Ethex Corp and FDA notified healthcare professionals of a voluntary recall of five generic products (Propafenone HCl Tablets, Isosorbide Mononitrate Extended Release Tablets, Morphine Sulfate Extended Release Tablets, Morphine Sulfate Immediate Release Tablets, and Dextroamphetamine Sulfate Tablets).

The products were recalled because they may contain oversized tablets. Oversized tablets may contain more than the intended levels of the active drug ingredient that could result in patients receiving as much as twice the expected dosage of these drugs, which could cause serious or life-threatening consequences.

Overdoses can include arrhythmias and low blood pressure with Propafenone HCl; fainting and low blood pressure with Isosorbide Mononitrate; respiratory depression and low blood pressure with Morphine Sulfate; and rapid heart rate and high blood pressure with Dextroamphetamine Sulfate. Patients who experience any adverse reactions to these drugs should contact their healthcare professional immediately. See the manufacturer’s recall notice for specific lot numbers of the products affected by this recall.

Read the entire MedWatch 2008 Safety Summary, including a link to the manufacturer’s recall notice regarding the above issue at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Ethex

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Tags: pain blog, chronic pain blog, pain relief, drug recall, Propafenone HCl Tablets, Isosorbide Mononitrate Extended Release Tablets, Morphine Sulfate Extended Release Tablets, Morphine Sulfate Immediate Release Tablets, morphine, Dextroamphetamine Sulfate Tablets